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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05794165
Other study ID # HSC-MS-22-1102
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date September 5, 2023
Est. completion date March 2027

Study information

Verified date April 2024
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if additional interventions will assist with decreasing the risk and/or severity of thromboembolism (clotting complications) in patients who have experienced a major traumatic event.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 314
Est. completion date March 2027
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Highest level of trauma activation or upgrade to highest level - Polytraumatic injuries OR pelvic/long bone fracture - Admission to trauma ICU or Surgical Intermediate Care Unit (SIMU) - Informed consent obtained Exclusion Criteria: - Prisoners (defined as those directly admitted from correctional facility) - Known or suspected pregnancy - = 20% total body surface area (TBSA) burned - Nonsurvivable head injuries - Known hematologic or immunologic disorders - Known prehospital anticoagulant use - Patients initially placed on unfractionated heparin for thromboprophylaxis - Known allergy to Antithrombin or it's components - Enrollment in another interventional study unless approved by Trial Principal Investigator

Study Design


Intervention

Drug:
Thrombate infusion
Bolus intravenous infusion of Thrombate will be given to achieve antithrombin (AT) activity levels at 150% before the 3rd dose of Enoxaparin. The dose will be based on patient weight.
Placebo
Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston Grifols Shared Services North America, Ind.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with incidences of venous thromboembolism (VTE ) 14 days post hospital admission
Primary Number of participants with incidence of antifactor Xa (anti-FXa) of =0.2 IU/mL 14 days post hospital admission
Secondary Time taken to achieve anti-FXa of =0.2 IU/mL 14 days post hospital admission
Secondary Number of enoxaparin dose escalations from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Secondary Number of incidences of participants with other thrombotic complications (arterial thrombosis, myocardial infarction, stroke) from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Secondary Number of incidences of participants with bleeding events (interoperative bleeding, abdominal bleeding) from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Secondary Number of hospital free days from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Secondary Number of Ventilator free days from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Secondary Number of ICU free days from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Secondary Level of Anti-FXa from the time of hospital admission up to hospital day 7
Secondary Antithrombin (AT) activity level from the time of hospital admission up to hospital day 7
Secondary Change in level of the endothelial marker syndecan-1 as assessed by a blood test time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7
Secondary Change in level of the endothelial marker thrombomodulin as assessed by a blood test From the time of hospital admission to day 7
Secondary Change in level of Inflammatory marker Tumor necrosis factor alpha (TNFa) as assessed by a blood test From time of hospital admission to day 7
Secondary Change in level of Inflammatory marker Interleukin-8 (IL-8) as assessed by a blood test From time of hospital admission to day 7
Secondary Change in level of Inflammatory marker Interleukin-6(IL-6) as assessed by a blood test time of hospital admission, day1, day2, day 3, day 4, day 5, day6, day 7
Secondary Change in level of Inflammatory marker Interleukin-1 beta (IL1b) as assessed by a blood test From time of hospital admission to day 7
Secondary Change in level of Inflammatory marker Interleukin-1 alpha (IL1a) as assessed by a blood test From time of hospital admission to day 7
Secondary Change in level of Inflammatory marker Interferon -gamma (INFg) as assessed by a blood test From time of hospital admission to day 7
Secondary Number of participants with In-hospital mortality from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
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